Mankaney Gautam N, Ando Masakazu, Dahdal David N, Burke Carol A
Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.
Ferring Pharmaceuticals Inc, Parsippany, NJ, USA.
Therap Adv Gastroenterol. 2021 Jun 28;14:17562848211024458. doi: 10.1177/17562848211024458. eCollection 2021.
Selecting a bowel preparation for patients with renal impairment or diabetes requires special consideration. We aimed to describe the effect of baseline renal impairment or diabetes on the safety, efficacy, and tolerability of low-volume sodium picosulfate, magnesium oxide, and citric acid (SPMC) ready-to-drink oral solution bowel preparation.
A secondary analysis was performed from a randomized, assessor-blinded study of SPMC oral solution bowel preparation in participants with mild or moderate baseline renal impairment or diabetes. Primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of ascending colon cleansing from the Boston Bowel Preparation Scale (BBPS), and selected results from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs), adenoma detection, and laboratory evaluations.
Similar overall colon cleansing was demonstrated in the subgroups, with >85% of participants in any subgroup rated as responders by the AS, and >92% of participant responders by the BBPS. Most participants reported a tolerable bowel preparation, regardless of baseline renal impairment or diabetes history. Safety of SPMC oral solution was similar between all subgroups and the overall cohort. For the mild renal impairment, moderate renal impairment, and diabetes subgroups, respectively, commonly reported, drug-related AEs were nausea (2.6%, 5.3%, 1.4%) and headache (2.2%, 2.6%, 4.3%).
Ready-to-drink SPMC oral solution demonstrated efficacious colon cleansing in patients with baseline mild/moderate renal impairment or diabetes, with a tolerable bowel preparation reported by most.
ClinicalTrials.gov identifier: NCT03017235.
为肾功能不全或糖尿病患者选择肠道准备方案需要特别考虑。我们旨在描述基线肾功能不全或糖尿病对低容量复方聚乙二醇电解质散（含匹可硫酸钠、氧化镁和柠檬酸，SPMC）即饮型口服溶液肠道准备的安全性、有效性和耐受性的影响。
对一项关于SPMC口服溶液肠道准备的随机、评估者盲法研究进行二次分析，该研究的参与者为基线轻度或中度肾功能不全或糖尿病患者。主要疗效终点（“反应者”）是在改良的阿龙奇克量表（AS）上获得“优秀”或“良好”评分的参与者比例。次要疗效结果是波士顿肠道准备量表（BBPS）中升结肠清洁质量，以及梅奥诊所肠道准备耐受性问卷的选定结果。安全性评估包括不良事件（AE）、腺瘤检测和实验室评估。
各亚组的总体结肠清洁效果相似，任何亚组中>85%的参与者被AS评为反应者，BBPS评分为反应者的参与者>92%。无论基线肾功能不全或糖尿病病史如何，大多数参与者报告肠道准备可耐受。所有亚组与总体队列中SPMC口服溶液的安全性相似。对于轻度肾功能不全、中度肾功能不全和糖尿病亚组，常见的与药物相关的AE分别为恶心（2.6%、5.3%、1.4%）和头痛（2.2%、2.6%、4.3%）。
即饮型SPMC口服溶液在基线轻度/中度肾功能不全或糖尿病患者中显示出有效的结肠清洁效果，大多数患者报告肠道准备可耐受。
ClinicalTrials.gov标识符：NCT03017235。
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